FDA's Caution on Device Manufacturers / Designers Reliance on Outside Test Labs:

"The FDA’s Center for Devices and Radiological Health (CDRH) is vigilant in ensuring data submitted to the FDA can be relied upon to assess the effectiveness, safety, or risk of a device. The FDA has noted an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors. This has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions rely on such data. In addition to obvious negative impacts to sponsors, these adverse determinations caused by unreliable testing data may also delay or reduce access to new devices that the FDA ultimately authorizes for patients and health care providers and increase the potential for disruption in the supply chains for devices.

Sponsors of device studies and manufacturers of devices are reminded to carefully evaluate the third parties they engage to conduct safety, performance, and cybersecurity testing and to independently verify all testing results before submitting to the FDA."

-- https://www.fda.gov/medical-devices/industry-medical-devices/notifications-data-integrity-medical-devices?utm_medium=email&utm_source=govdelivery

They issued Warning Letters and a General Correspondence Letter already on this problem with a non-compliant company and a 3rd party testing facility - CCIC Huatongwei International Inspection (Suzhou) Co., Ltd. .

- jel@jelincooln.com  06/26/26